The global study enrolled 161 patients, with topline results expected in Q1 2027 following completion of treatment and the final follow-up phase.
Calluna Pharma AS, a clinical-stage biotechnology company developing antibody therapies for inflammatory and fibrotic diseases, has announced the completion of dosing in its Phase 2 AURORA study evaluating CAL101 in adults with idiopathic pulmonary fibrosis (IPF).
The Independent Data Monitoring Committee (IDMC) has also completed its final review of unblinded safety data from all 161 enrolled patients and identified no findings warranting changes to the study.
The fully enrolled global trial has now entered its final follow-up phase, with topline results expected in the first quarter of 2027.
Key Highlights
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Trial milestone: Dosing completed in the Phase 2 AURORA study of CAL101.
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Patient enrollment: 161 patients enrolled across more than 50 clinical sites worldwide.
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Safety monitoring: The IDMC identified no findings requiring modifications to the study following its final review of unblinded safety data.
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Study design: Randomized, double-blind, placebo-controlled Phase 2 trial.
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Primary endpoint: Change from baseline in forced vital capacity (FVC), a measure of lung function.
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Next milestone: Topline results expected in Q1 2027.
CAL101: Targeting Inflammatory and Fibrotic Signalling
CAL101 is an investigational, systemically administered monoclonal antibody designed to neutralize extracellular S100A4, a damage-associated molecular pattern protein involved in inflammatory and fibrotic signalling.
S100A4 is associated with the activation and proliferation of fibroblasts, as well as pro-fibrotic immune responses that contribute to the progression of fibrotic diseases.
By targeting S100A4 as an upstream amplifier of multiple disease-related pathways, CAL101 is designed to interrupt pathological signalling while avoiding broad suppression of normal physiological processes.
The ongoing clinical program is evaluating whether this mechanism can translate into meaningful clinical benefits for people living with IPF.
Phase 2 AURORA Study: Design and Objectives
AURORA is a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate the efficacy and safety of CAL101 in adults with IPF.
| Study parameter | Details |
|---|---|
| Investigational therapy | CAL101 |
| Indication | Idiopathic pulmonary fibrosis (IPF) |
| Clinical phase | Phase 2 |
| Total enrollment | 161 patients |
| Clinical sites | More than 50 |
| Study regions | United States, United Kingdom, European Union, Turkey, and South Korea |
| Randomization | 3:2 ratio |
| Treatment period | Six months |
| Administration | Monthly intravenous infusions of CAL101 or placebo |
| Primary endpoint | Change from baseline in forced vital capacity (FVC) |
| Additional assessments | Circulating biomarkers and quantitative high-resolution computed tomography imaging |
| Expected topline results | Q1 2027 |
The primary endpoint, FVC, measures the volume of air a person can forcibly exhale after taking a deep breath. Changes in FVC help researchers assess lung function and disease progression in IPF.
Additional biomarker and imaging assessments are intended to provide further insights into the biological and structural effects associated with treatment.
The trial is registered on ClinicalTrials.gov under identifier NCT06736990.
Company Commentary
Jonas Hallén, M.D., Ph.D., co-founder and chief medical officer of Calluna Pharma, described completion of dosing as an important milestone in the AURORA program.
He acknowledged the contributions of participating patients and families, investigators, study coordinators, clinical site teams, and the IDMC. With treatment completed and follow-up continuing, the company is now preparing for the anticipated Q1 2027 topline results.
Understanding Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis is a progressive lung disease characterized by abnormal wound healing that causes lung tissue to become thickened and scarred. As fibrosis advances, the lungs become less able to transfer oxygen efficiently, making breathing increasingly difficult.
IPF primarily affects older adults and can lead to respiratory failure and death. Although treatment options have advanced, the disease remains a significant clinical challenge, creating a need for additional therapies that may preserve lung function and be suitable for long-term management.
CAL101 is being investigated as a potential new approach that targets inflammatory and fibrotic signalling pathways involved in disease progression.
About Calluna Pharma
Calluna Pharma is a global clinical-stage biotechnology company developing selective antibody therapies for inflammatory and fibrotic diseases.
Its research strategy focuses on targeting upstream amplifiers of disease-related signalling pathways, with the aim of interrupting pathological processes while preserving normal physiological functions.
Outlook
Completion of dosing marks a key milestone for CAL101 as it advances through clinical development for idiopathic pulmonary fibrosis. The IDMC's final safety review identified no findings requiring study modifications, and the trial has moved into its final follow-up phase.
Topline results expected in Q1 2027 will provide the next major update on CAL101’s clinical development, including findings from the study’s lung-function endpoint and additional biomarker and imaging assessments.
CAL101 remains investigational, and its safety and efficacy for treating IPF have not yet been established.
